Significant QoL Improvement With LDV/SOF in Adolescents With HCV GT1

BOSTON, MA—In a study of 100 adolescent patients with hepatitis C virus (HCV) genotype (GT) 1 infection, treatment with ledipasvir/sofosbuvir (LDV/SOF) showed improvement in quality of life (QoL) during and after achieving sustained virologic response (SVR), according to a study presented at The Liver Meeting® 2016.

Standard HCV treatment for children is pegylated interferon plus ribavirin with low efficacy accompanied by toxicity that can impair the physical aspects of their QoL. Zobair M. Younossi, MD, from The Inova Fairfax Hospital, Falls Church, VA, and coauthors evaluated the impact of LDV/SOF on the QoL of pediatric HCV patients. The study enrolled 100 adolescents with HCV aged 12–17 years. They were treated with LDV/SOF 90mg/100mg daily for 12 weeks.

QoL was evaluated using the Pediatric QoL Inventory that involves 4 domains: physical, emotional, social, and school. The researchers used univariate and multivariate analysis to compare QoL scores at various time points to baseline. The mean age was 14.7 years with 17% having ADHD, 7%, depression, and 1%, cirrhosis.

After 12 weeks of treatment with LDV/SOF, 97% of patients achieved SVR12.

At baseline, parent-reported domains scores were lower than self-reports completed by the children by 6.7–7.9 points (P<0.01). By the end of treatment, the parent-reported QoL scores demonstrated a significant improvement (+5.7 to +8.1 points; P<0.04) whereas scores reported by children “were not significantly different from baseline.”

“By post-treatment Week 12, most of the QoL scores reported by the parents remained higher than baseline (+4.7 to +7.5; P<0.01),” reported Dr. Younossi. The Emotional Functioning domain score as reported by children also showed improvement from baseline (+4.3; P=0.0009); effects were sustained until Week 24 of follow-up. Though parents reported lower scores prior to treatment, their scores increased and became comparable to those reported by the children, noted the authors.

After multivariate adjustment for age and gender, history of anxiety and panic disorders was the only consistent correlate of QoL impairment (P≤0.05).